Abstract
Introduction
Soft-tissue balancing methods in TKA have evolved from surgeon feel to digital load-sensing tools. Such techniques allow surgeons to assess the soft-tissue envelope after bone cuts, however, these approaches are ‘after-the-fact’ and require soft-tissue release or bony re-cuts to achieve final balance. Recently, a robotic ligament tensioning device has been deployed which characterizes the soft tissue envelope through a continuous range-of-motion after just the initial tibial cut, allowing for virtual femoral resection planning to achieve a targeted gap profile throughout the range of flexion (figure-1). This study reports the first early clinical results and patient reported outcomes (PROMs) associated with this new technique and compares the outcomes with registry data.
Methods
Since November 2017, 314 patients were prospectively enrolled and underwent robotic-assisted TKA using this surgical technique (mean age: 66.2 ±8.1; females: 173; BMI: 31.4±5.3). KOOS/WOMAC, UCLA, and HSS-Patient Satisfaction scores were collected pre- and post-operatively. Three, six, and twelve-month assessments were completed by 202, 141, and 63 patients, respectively, and compared to registry data from the Shared Ortech Aggregated Repository (SOAR). SOAR is a TJA PROM repository run by Ortech, an independent clinical data collection entity, and it includes data from thousands of TKAs from a diverse cross-section of participating hospitals, teaching institutions and clinics across the United States and Canada who collect outcomes data. PROMs were compared using a two-tailed t-test for non-equal variance.
Results
When comparing the baseline PROM scores, robotic patients had equivalent womac knee stiffness (p=0.58) and UCLA activity scale (p=0.38) scores but slightly higher womac knee pain (p=0.002) and functional scores (p=0.014, figure-2). While all scores improved over time, the rate of improvement was generally greater at 6 months than at three months when comparing the two groups, with statistically higher six-month scores in the robotic group for all categories (p<0.001). Overall patient satisfaction in the RB cohort was 90.3%, 95.0% and 91.8% at 3M, 6M and 1Y, respectively (figure-3). Average length of hospital stay was 1.6 days (±0.8). Surgical complications in this cohort included one infection four months post-op, 6 post-operative knee manipulations, one pulmonary embolism and one wound dehiscence from a fall.
Discussion
We postulated that the ability to use gap data prospectively under known loading conditions throughout the knee range-of-motion would allow femoral cut planning that resulted in optimum balance with fewer releases and better long-term results. While the study group patients had slightly higher baseline knee pain and function than registry patients and showed similar net improvements at the three-month mark, study patients showed significantly better improvements in all areas between three months and six months compared to registry data. WOMAC stiffness and UCLA activity scores were equal between the two groups at baseline and significantly improved at three months and six months. Better ligament balance may have significantly contributed to these gains and to the high rates of satisfaction reported in the study patients compared to the historical literature. Limitations to this study include the small number of patients and the lack of a closely matched control group.
For any figures or tables, please contact authors directly.
